Overdosed America (10 page)

The
Times
article described the dramatic meeting of the American Society of Clinical Oncology that took place in 1999, three years after Ms. Fletcher received her treatment. The much-awaited results of five randomized trials of bone marrow transplantation for women with advanced breast cancer were presented. The four largest trials reported no benefit. Only the smallest study, done by the same researcher in South Africa, reported a survival advantage.

The response to this bad news provides a peek into how American health care is shaped. A press release issued by the American Society of Clinical Oncologists (including oncologists who perform transplants) said that the studies “report mixed early results.” The president of the society recommended that the therapy continue to be offered. The president of the National Breast Cancer Coalition, Fran Visco, said, “How can anybody look at these data and think this is something we should continue doing or that [the results of the studies] are inconclusive?” But Dr. William H. West, the chairman of the for-profit Response Oncology, said that it was “an oversimplification” to consider discontinuing this therapy.

One year after the American Society of Clinical Oncology meeting, American researchers made a site visit to the South African researcher’s laboratory and
found that his data were fraudulent
.
The researcher’s article was retracted
by the
Journal of Clinical Oncology,
and he was fired from his university post. Finally, in 2000, this unfortunate chapter in medical history was brought to an end when the results of a study published in the
New England Journal of Medicine
failed to show any benefit
from high-dose chemotherapy followed by bone marrow transplantation.
The accompanying editorial
laid the issue to rest:
“this form of treatment for women
with metastatic breast cancer has been proved to be ineffective and should be abandoned.. . .” But this was four years too late to save Ms. Fletcher from her horrific experience. She never fully recovered from the procedure, and died several months later.

Ms. Fletcher’s experience
is not an isolated case. Every day wasteful diagnostic tests and therapies, from the serious to the mundane, are prescribed in the name of “state-of-the-art” health care: heart surgery for which no benefit has been shown; treatment with expensive brand-name medications when drugs costing only one-fifteenth as much are more effective; MRIs performed simply to satisfy patients’ or consultants’ curiosity (and often leading to erroneous diagnostic assumptions); expensive drugs when lifestyle changes would be far more effective at protecting health; tests and consultations that are very unlikely to lead to better outcomes. Multiplied countless times, these tests and therapies show how the U.S. health care system can be so expensive, yet not produce better results.

When I first read of the poor performance of the U.S. health care system I was incredulous. But as I confirmed these findings with data from multiple sources and began to understand the underlying causes, my skepticism gave way to a sense of vindication. I had been trained to believe that carefully reading the medical journals, following experts’ recommendations, and keeping up with continuing education would ensure that I was bringing the best possible care to my patients. I had been practicing mainstream medicine, along with a few clearly effective alternative remedies, but over the last few years, I had become increasingly aware that this wasn’t good enough.

Now I knew why. My discoveries about the myth of excellence in American health care led me to realize that the commercialization of medicine wasn’t just causing doctors to prescribe unnecessary drugs and procedures. It was actually subverting the quality of medical care. I must respectfully disagree with President George W. Bush’s comments about American health care in a speech made to the Illinois Medical Society in June 2003:
“One thing is for certain
about health care in our country, is that we’ve got the best health care system in the world and we need to keep it that way.” The only thing that appears to be certain about health care in our country is that we aren’t getting the health we’re paying for.

Mrs. Clark had
been coming to me for her nongynecological primary care for about 10 years. She was a cheerful, attractive, and well-dressed woman in her early sixties with stylishly short brunette hair who exuded confidence and positive energy. For about 15 years, since her periods had started to become irregular, Mrs. Clark had been going to her trusted female gynecologist for annual pelvic and breast exams, PAP smears, and mammograms, and to monitor her hormone replacement therapy (HRT). When we first met, Mrs. Clark let me know that she felt more comfortable discussing personal issues with her gynecologist, so at her annual exams I would make only general inquiries and therefore did not get to know her as well as most of my other patients. I knew that her family was doing well, her lifestyle was unusually healthy, and she had no significant medical problems.

When Mrs. Clark’s elderly father moved into the area, I became his doctor as well. As I observed her deft handling of her father’s needs and demands, I began then to get a sense of Mrs. Clark’s unusual competence. She shared with me how difficult her childhood relationship with her father had been. I could see that he still had the potential to be difficult—especially with her. She worked hard to get things right. Her requests of me and my office were reasonable, and she advocated well on behalf of her family and herself.

Then she was diagnosed with breast cancer. Mrs. Clark told me that within a day or two after she first felt a lump in her left breast, she had seen her gynecologist, who arranged for a needle biopsy. The lump was malignant. A surgeon removed the tumor, leaving the rest of her breast intact, but biopsies done at the time of her lumpectomy showed that cancer cells had already spread to several lymph nodes. She went on to have a complete mastectomy, including removal of the lymph nodes under her arm.

During our next 15-minute appointment, she brought me up to date on the details of her care. She had recovered well from her surgeries and was about to begin chemotherapy. She was very happy with the care provided by a local cancer specialist. This positive attitude would serve her well in meeting the challenge of this illness, yet I worried that it might make it difficult for her to come to grips with the inevitable sadness and fear that accompany cancer.

Toward the end of the appointment, I asked if she would like to talk more in depth about her situation. She said that she would. At the time, I was teaching a course at Harvard Medical School about the role of the doctor-patient relationship in the healing process, and I asked Mrs. Clark if I might tape our conversation so my students could get an idea of what this experience was like for her. I sensed that the opportunity to contribute to the education of medical students would make it easier for her to get “down and dirty” with her feelings.

When Mrs. Clark returned several days later, she expressed confidence that her treatment would be successful. She told me that her illness had brought her even closer to her husband and children, and that her church was a great source of personal support and spiritual comfort. The only time she cried was when she spoke about the prospect of losing her hair during chemotherapy. But she laughed later as she recounted the banter with her husband as they had contemplated different “looks” when shopping for a wig.

Yet Mrs. Clark was upset about two issues related to her medical care. She described her discomfort with an encounter she’d had with an oncologist at one of the major teaching hospitals in Boston. She recalled how the doctor had remained standing while she and her husband were seated, trying to persuade her to enroll in an experimental trial of aggressive chemotherapy. She said he did not seem interested in her as a person, and after she declined his offer, he appeared to lose all interest in her care as well. She and her husband were left with the sense that the oncologist’s only interest was to enroll another body in his chemotherapy study.

More troubling to Mrs. Clark was the fact that there was about a 50-50 chance that the hormones she had been taking for 12 years, ostensibly to protect her health, had actually caused her breast cancer. Mrs. Clark was aware, as was I, of the finding published in JAMA almost a year before her cancer had been diagnosed that a woman’s
risk of breast cancer increases by 8 percent
for each year that she takes combined hormone replacement therapy (HRT). Mrs. Clark could not understand why her trusted gynecologist had prescribed HRT 12 years earlier when, with only very mild hot flashes, she had entered menopause. Nor could she understand how her gynecologist could have been so confident that she should remain on the hormones indefinitely. Why, she asked, didn’t the JAMA article have more of an impact on doctors’ opinions about the routine treatment of postmenopausal women with HRT?

Mrs. Clark had only minimal side effects from the chemotherapy administered by her local oncologist, but she did lose her hair. She came through this phase of her treatment very well, and was proud to show me when her hair had grown back enough so that she could stop using her wig. When I next spoke with her local oncologist, I asked if by refusing to participate in the clinical trial Mrs. Clark had passed up an opportunity to receive more effective therapy. The oncologist answered that the best evidence we have to date shows that this aggressive therapy was very unlikely to be more effective than the more mild chemotherapy regimen that Mrs. Clark had chosen. Perhaps Mrs. Clark had trusted her gynecologist too much, but she did not make the same mistake again.

Mrs. Clark had done the best that she could with the information she had at the time. She is a well-educated person who takes excellent care of herself, seeking the best medical care and following her trusted gynecologist’s advice. Yet she ended up profoundly disappointed with the medical system that had urged her to receive hormone replacement therapy, ostensibly to protect her health, that could very well have caused her cancer.

Mrs. Clark, as we all know, is not alone. Over the last several decades, millions of healthy women entering menopause were urged to take HRT. Doctors, researchers, and newspaper and magazine articles all told the same story: The scientific evidence is overwhelming that HRT will protect postmenopausal women’s health and improve the quality of their lives. Hormone pills became the top-selling drugs for several years running—until it became clear that all the compelling science supporting the use of HRT was nothing but a house of cards. HRT not only doesn’t decrease the risk of heart disease, strokes, or Alzheimer’s disease—it
increases
these risks.

In this era of modern, evidence-based medicine, how could so many women have been placed on drugs that turned out to be bad for their health?

Menopause, the end of menstruation, is the second most significant biological transition in a woman’s life, the first being the onset of menstruation. The high levels of reproductive hormones necessary for childbearing shift down to the lower levels needed during the post-reproductive part of a woman’s life. In 1997, Dr. Susan Love, a nationally recognized breast surgeon and women’s health advocate, wrote a courageous and what turned out to be right-on-the-mark book about menopause and hormones.
Dr. Susan Love’s Hormone Book
explains that in menopause,
“The hormonal dance doesn’t end;
the band just strikes up another tune.” Estrogen production does not cease entirely after menopause. The cells that maintain the internal structure of the ovary (the stroma), as well as the adrenal glands and fat tissue, combine to produce about one-tenth as much estrogen after menopause as was produced before.

Estrogen levels do not, however, decline steadily as women go through menopause. They fluctuate as the body adjusts to its new “tune.” Hot flashes and night sweats are caused by the hypothalamus (the part of the brain that controls body temperature) responding to fluctuating levels of estrogen in the blood.

On a personal and social level, menopause is the time when women are able to shift their focus beyond the needs of young children.
Dr. Christiane Northrup
, in her book
The Wisdom of Menopause,
talks of menopause as a time when many women rekindle their “concerns with social injustices, the political interests, and the personal passions that were sublimated in the childbearing years,” and explore new interests and sources of meaning.

With change, however, also comes vulnerability. Much like the acute sense of vulnerability that so many adolescent girls experience, the transition into the post-reproductive years—especially in our youth-oriented society—also creates anxiety. Medicalization of this transition often increases many women’s fears about aging and chronic disease and at the same time makes them vulnerable to commercial exploitation—especially by the drug companies.

Premarin (brand name for estrogen) was approved by the FDA in 1942
for the treatment of symptoms associated with menopause, primarily hot flashes, night sweats, and vaginal dryness. Wyeth-Ayerst, the manufacturer of Premarin, still holds the patent for the manufacturing process. Premarin was named for its source: PREgnant MARres’ urINe. During pregnancy, mares increase their production of estrogen several hundredfold. Most of this extra estrogen is excreted by the kidneys into the urine. Horse estrogen is similar to human estrogen, a fact that led Wyeth-Ayerst to an inexpensive source for Premarin: pregnant mares. Wearing a urine collection bag and kept in a small stall,
each mare produced enough estrogen
to treat about 150 women.

Only a minority of women have menopausal symptoms that are severe enough to require medical therapy. As Dr. Love points out, only one out of six women going through menopause experiences “really bothersome” hot flashes; one out of three rates her hot flashes as “somewhat bothersome”; one out of eight experiences “really bothersome” night sweats; and fewer than one in 30 experiences “really bothersome” vaginal dryness. Half of the women going through menopause have no hot flashes at all. Symptoms usually last no more than two to five years—only about one out of 20 women has troublesome symptoms that persist long after the transition through menopause is complete. Clearly, restricting the use of Premarin to women with troublesome menopausal symptoms limited its potential market greatly. If more drugs were to be sold, new reasons to take estrogen would have to be found.